Method Validation

Meet laboratory regulatory compliance demands.

Evaluate and verify the analytical and diagnostic performance of methods.

Method validation is essential to confirm that an analytical procedure is suitable for its intended use. Used by most of the top-10 IVDs, the reference laboratories, the FDA, and thousands of independent labs, Analyse-it is essential throughout the R&D phases, in-house validation and performance testing, and in streamlining 510k submissions.

Even in the laboratory you need to confirm the ability to meet the manufacturer’s claims or the needs of your users before putting a method into routine use, or demonstrate performance is on track after a proficiency test failure or other changes to your measuring system. Analyse-it is essential for any laboratory complying with CLIA or other local laboratory regulations.

We use Analyse-it for the analysis of data necessary to file 510k. We chose Analyse-it because it works in Excel, includes CLSI protocols, and, unlike EP-Evaluator, lets us analyze data directly from equipment without typing.

Thomas D Harrigan, Ph.D.

Technical Product Manager, Reagent Technology

Alfa Wassermann Diagnostic Technologies, LLC

Method comparison

Establish the trueness of a method against reference method. And ensure the comparability between two methods when replacing your current method so you can be confident the change won’t affect clinical decisions. Or, verify the difference between methods meets the manufacturer’s claims or other performance criteria.

Precision

Establish the precision of a method over many days, runs and levels. Or, verify that your laboratory can achieve the manufacturer's claim or other performance criteria.

Linearity

Establish linearity over the measuring interval. Or, use commercial standards to ensure the correct calibration of the measuring system throughout analytical measuring range.

Reference intervals

Establish reference intervals for a method, or verify existing intervals are transferable between laboratories or when changing methods.

Compliant with CLSI C28 and IFCC, includes parametric and non-parametric methods.

Diagnostic performance

Establish the diagnostic ability of a quantitative or qualitative test to discriminate between two outcomes using ROC analysis and ROC curve plots. And compare the performance of many tests to decide which is best using Delong-Delong comparisons.

And more

In addition you get the full complement of statistics and plots in our Analyse-it package.

We use Analyse-it frequently for our verification and pre-verification work, in accordance with CLSI guidelines for in-vitro diagnostics. It’s saved time and effort compared to the hodge-podge of applications we used before, JMP, SAS, etc...

Brian Noland, Ph.D.

Principle Scientist, Product Development

Biosite / Inverness Medical Innovations

Integrated into Microsoft Excel for quick and convenient statistical analysis and data visualization.

Data analysis without leaving Excel.

Analyse-it runs entirely in Microsoft Excel. No data transfer to another application, leaving your data locked in a separate application.

And no learning curve because you never leave the familiar Excel environment. Prepare your data in Excel: type it in, import it from a database, download it live from a manufacturing process, or receive from a colleague it by e-mail. Then Analyse-it!

The only limit is the size of a worksheet – if you call over 1 million rows a limitation!

Exclude data, filter, rinse & repeat.

Data analysis is iterative. You start analysis and then discover an observation to exclude, that analysis should focus on a subset where an effect is present, that the latest data from a live process needs to be added, or that a different model should be used. Or simply it’s time to go home and rest your brain.

Whatever the reason, you can pick-up any analysis where you left off. Recalculate an analysis to see how changes in the data, filter, and excluded observations affect the statistics and plots. Or edit an analysis to change the statistics or plots.

Print-ready analysis reports.

Statistical analysis is hard enough, without wasting your time formatting the output for presentation.

Analyse-it saves you the effort. Statistics are presented to a sensible number of decimal places relative to your data, with the computation method clearly shown. Plots are standard Excel charts, not static images, with important data points highlighted and labelled so you can easily find them. And page breaks are included so plots and tables don’t split across pages. Just click print.

Save, export and share work.

Save analyses in an Excel workbook just like any other Excel worksheet. Then, anyone with Microsoft Excel can view your analysis. Anyone with Analyse-it can recalculate or change your analysis. And anyone can use your analysis as a template for a future analysis -- unburdening the statistician and helping colleagues easily run common analyses.

If you need a custom report or presentation, simply copy and paste statistics, tables and plots into Word, PowerPoint or any other Windows application.

I used Analyse-It for many product development, product troubleshooting, and technology evaluation activities... your product was the easiest to use, was accurate, and produced publication ready reports.

Stanley F. Cernosek, Ph.D.

Clinical Chemistry Reagent Development Manager

Beckman Coulter, Inc.

Validated, tested, reliable.

When you’re using statistical software to make decisions about your business, or decisions that affect the life of patients, you need software you can trust. The statistics have to be correct. With over 20-years experience, developing statistical software, you can rely on us. Read more about us.

Trusted by academia and business.

Analyse-it is used by over 25,000 customers, in more than 105 countries around the world. It’s cited in 1,000’s of peer-reviewed articles published in a wide-range of respected journals. And it’s used in all kinds of applications; for making decisions in business & industry, for analysing clinical & medical research, and in teaching and education.

Join the thousands of others that trust and rely on Analyse-it everyday.

No reliance on Excel functions.

Some people say Microsoft Excel isn’t suitable for statistical analysis. The built-in statistical and distribution functions maybe aren’t. That’s why Analyse-it doesn’t use any of them – not even one!

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ABOUT ANALYSE-IT

Analyse-it is the leading statistics software for Microsoft Excel.
First released in 1997, Analyse-it surpasses traditional statistical software in ease of use, features and price. Over 25,000 customers now rely on Analyse-it for in-depth statistical analysis and visualization in Excel.